Sirolimus-Eluting Stent and a Standard Stent in the Prevention of Restenosis in Small Coronary Arteries - SES-SMART

Description:

The goal of the trial was to evaluate the use of sirolimus-eluting stents (SESs) compared with bare stents in patients with small vessels undergoing percutaneous revascularization.

Study Design

Study Design:

Patients Enrolled: 257
Mean Follow Up: Eight months
Mean Patient Age: Mean age 64 years
Female: 28

Patient Populations:

Percutaneous revascularization for stable or unstable angina or silent myocardial ischemia, with a de novo atherosclerotic lesion in a small coronary segment (diameter ≤2.75 mm)

Primary Endpoints:

Binary in-lesion restenosis rate at eight-month follow-up

Secondary Endpoints:

Eight-month in-lesion minimal luminal diameter, late loss index, target lesion revascularization, and MACE

Drug/Procedures Used:

Patients with stable or unstable angina and a de novo atherosclerotic lesion in a small coronary segment (diameter ≤2.75 mm), were randomized to receive either a SES (n=129) or an uncoated stent (n=128).

Principal Findings:

There was no difference in percent stenosis at baseline (66.9% for SES vs. 66.8% for bare stent, p=NS) or postprocedure (22.4% vs. 22.9%, p=NS). At eight-month angiographic follow-up, the primary endpoint of binary in-lesion stenosis was lower in the SES group compared with the bare stent arm (9.8% vs. 53.1%, p<0.001). Percent diameter stenosis was also smaller in the SES arm (29.7% vs. 50.8%, p<0.001), while minimum lumen diameter was larger in the SES arm (1.7 mm vs. 1.1 mm, p<0.001).

Major adverse cardiac events (MACE) were lower in the SES arm (9.3% vs. 31.3%, p<0.001), driven primarily by a reduction in target vessel revascularization (7% vs. 21.1%, p=0.002) and myocardial infarction (1.6% vs. 7.8%, p=0.04). By eight months, four subacute stent thromboses occurred in the bare stent group, and one in the SES group.

Interpretation:

Among patients undergoing percutaneous revascularization for stable or unstable angina, with a de novo atherosclerotic lesion in a small coronary segment (diameter ≤2.75 mm), use of an SES was associated with a reduction in binary in-lesion restenosis at eight-month follow-up compared with use of an uncoated stent. These data extend the findings of the SIRIUS, C-SIRIUS, and E-SIRIUS trials, which evaluated use of SESs in patients with simple de novo coronary lesions in larger vessels (2.5-3.5 mm diameter). The postprocedure percent stenosis was relatively high in both arms (~22%), which is likely due to the difficulty of dilatation and stenting in these patients with small arteries.

References:

Ardissino D, et al. Sirolimus-Eluting vs Uncoated Stents for Prevention of Restenosis in Small Coronary Arteries. JAMA. 2004;292:2727-2734.

Presented by Dr. Diego Ardissino, at the American College of Cardiology Annual Scientific Session, March 2004.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: Myocardial Infarction, Follow-Up Studies, Thrombosis, Drug-Eluting Stents, Dilatation, Constriction, Pathologic, Sirolimus, Stents


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